Adhesive Patch and Method of Using the Same

ABSTRACT

The disclosure provides, in part, adhesive patches for repairing damaged surfaces of health care devices. In one of its aspects the disclosure provides a method of repairing the surface of health care device by applying an adhesive patch over a damaged portion of the surface, the patch comprising a film layer and an adhesive layer. In another one of its aspects, the disclosure provides an adhesive patch for repairing the surface of a health care device comprising a film layer and an adhesive layer.

FIELD

The present disclosure generally relates to adhesive patches, forexample, patches for repairing damaged surfaces of health care devices.

BACKGROUND

A typical health care device undergoes significant use and wearthroughout its lifespan. Damage to the surface of the health caredevice, such as, tears, punctures, rips, burns, wear, cracks, and othersurface damage, is unattractive, unsanitary and presents potentialhealth risks. Increasingly, health care providers are becoming aware ofthe role that contaminated environmental surfaces play in thetransmission of pathogens. Patient care initiatives, particularlyinfection control efforts, are becoming more prevalent. At least 30% ofhealth care associated infections can be prevented by followinginfection prevention and control strategies (Haley R W, Culver D H,White J W, Morgan W M, et al. (1985) The nationwide nosocomial infectionrate: a new need for vital statistics. Am J Epidemiol. Vol. 121:159-67).One challenge in cleaning or disinfecting the surfaces of health caredevices is the occurrence of small tears and other damage to the surfaceof the device. Not only is routine cleaning of health care devicessuboptimal, but damaged surfaces typically cannot be fully cleaned ordisinfected thereby creating a potential reservoir for infectiousagents.

Health care devices used in hospital environments have been found to bea source of health care associated infections. Environmentalmicrobiological surveys have indicated that hospital devices (forexample, beds, tables, stools, wheelchairs, racks, trolleys, stretchers,mattresses, catheter-bag, and other furniture, equipment and articlesused in a hospital environment) can be contaminated with pathogens at ahigher incidence relative to other surfaces (see, for example, RamplingA, Wiseman S, Davis L., et al. (2001) Evidence that hospital hygiene isimportant in the control of methicillin-resistant Staphylococcus aureus.J Hosp Infect. Vol. 49:109-116; and Blythe D, Keenlyside D, Dawson S J,Galloway A. (1998) Environmental contamination due tomethicillin-resistant Staphylococcus aureus. J Hosp Infect. Vol.38:67-70). In addition, there have been reports of hospital mattressescontaminated with infectious agents, including for example, Pseudomonasaeruginosa, methicillin-resistant Staphylococcus aureus (MRSA),vancomycin-resistant Enterococci (VRE), Acinetobacter, and other fungaland viral pathogens. Hospital mattresses damaged by extensive use, tearsand sharp objects, such as needles, may create a potential reservoir forinfectious agents and a portal for entry and exit of infectious agents.Several studies have demonstrated that damaged mattresses have had arole in outbreaks, the transmission of disease to patients, and in somecases patient death (see Creamer E, Humphreys H. (2008) The contributionof beds to healthcare-associated infection: the importance of adequatedecontamination, J Hosp Infect. Vol. 69:8-23; Sherertz R J, Sullivan ML. (1985) An outbreak of infections with Acinetobactercalcoaceticus inburn patients: contamination of patients' mattresses. J Infect Dis. Vol.151:252-258; Moore E P, Williams E W. (1991) A maternity hospitaloutbreak of methicillin resistant Staphylococcus aureus. J Hosp Infect.Vol.19:5-16; Ndawula E M, Brown L. (1991) Mattresses as reservoirs ofepidemicmethicillin-resistant Staphylococcus aureus. Lancet. Vol.337:488.; Fujita K, Lilly H A, Kidson A, Ayliffe G A. (1981) Gentamicinresistant Pseudomonas aeruginosa infection from mattresses in a burnsunit. Br Med J. Vol. 283:219-220; Robertson M H, Hoy G, Peterkin I M.(1980) Anti-static mattress as a reservoir of pseudomonas infection. BrMed J. Vol. 280:831-832; and O'Donoghue M A, Allen K D. (1992) Costs ofan outbreak of wound infection in an orthopaedic ward. J Hosp Infect.Vol. 22:73-79). These studies discuss that damaged hospital mattressesmay harbour infectious agents and result in nosocomial infections, andintact mattresses or health care devices are preferred for appropriatecleaning, disinfection and infection prevention and control.

As a result, many health care providers have instituted policiesrequiring the replacement of health care devices having damaged surfacesor the replacement of the damaged components of the device. However,replacement of a health care device or its damaged components can becostly, may result in equipment downtime, and the likelihood of a tearor other surface damage occurring after replacement is high. Thus manyhealth care devices are left in a damaged state.

Prior art solutions exist to repair damaged surfaces of a variety ofnon-medical devices. In one solution, ready-mix glue is applied to thedamaged portion of the surface. However, this solution tends to bemessy, leaves the surface temporarily out of service, and may createtoxic fumes or be toxic through direct contact. In another solution,duct or other types of tape are applied to the damaged portion of thesurface. However, the edges of the tape tend to breakdown after extendeduse or following the application of liquids or body fluids. These edgescan be difficult to clean properly, thereby, creating an additionalpotential reservoir for infectious agents.

SUMMARY

The disclosure provides, at least in part, adhesive patches forrepairing damaged surfaces of health care devices.

In certain aspects the disclosure provides a method of repairing thesurface of health care device by applying an adhesive patch over adamaged portion of the surface, the patch comprising a film layer and anadhesive. In certain aspects, the disclosure provides an adhesive patchfor repairing the surface of a health care device comprising a filmlayer and an adhesive.

The film layer may comprise one or more of the following properties:adhesion or bonding to the adhesive or interlayer, anti-decubitus,heat-resistance, resistance to ultraviolet radiation, durability,flexibility, stretchable, breathability, cleanability, resistance tochemical cleaning products; anti-microbial properties, hypoallergenicand non-cytotoxic properties.

The adhesive may comprise one or more of the following properties:adhesion to film layer or interlayer and device surface,heat-resistance, pressure-resistance, resistance to ultravioletradiation, durability, flexibility, cleanability, resistance to chemicalcleaning products; plasticizer resistant, anti-microbial, hypoallergenicand non-cytotoxic properties.

As used herein, the term ‘patch’ refers to articles having a size andadhesion characteristics suitable for affecting a durable repair tohealth care devices such as, for example, mattresses used in hospitalbeds. In certain embodiments, the patches are generally planar in shapewith a film layer and an adhesive layer.

As used herein, “a” or “an” means “at least one” or “one or more”.

This summary does not necessarily describe all features of theinvention. Other aspects, features and advantages of the invention willbe apparent to those of ordinary skill in the art upon review of thefollowing description of specific embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a top plan view of a health care device having a damagedsurface.

FIG. 1B is a side elevation view of the health care device shown in FIG.1B.

FIG. 2A is a top plan view of the health care device shown in FIGS. 1Aand 1B having an adhesive patch applied to the damaged portion of thesurface of the health care device.

FIG. 2B is a side elevation view of the health care device shown inFIGS. 1A and 1B having an adhesive patch applied to the damaged portionof the surface of the health care device.

FIG. 3A is top plan view of the patch shown in FIGS. 2A and 2B.

FIG. 3B is side elevation view of the patch shown in FIGS. 2A and 2B.

DETAILED DESCRIPTION

The present adhesive patches comprise a film layer and an adhesive.

The film layer may be any suitable substance. For example, the filmlayer may comprise a thermoplastic or thermosetting polymer or acombination of polymers. Examples of thermoplastic polymers include, butare not limited to, polyacetals, polyolefins, polyacrylics,polycarbonates, polystyrenes, polyesters, polyamides, polyvinyl,polysulfonates, polysulfides, polythioesters, polysulfones,polysulfonamides, polyureas, polyurethane, or the like, and combinationsthereof. The present film layer may comprise a polyethylene,polyurethane, polypropylene, nylon, silicone, polyamide, polyester,polyvinyl, or the like, or combinations thereof. Preferably the filmlayer comprises a polyvinyl, polyurethane, or the like. Such films areavailable commercially from a variety of sources, such as, for exampleDartex Coatings Inc. (Nottingham, UK), DermaMed Coatings Company LLC.(Ohio, USA), Argotec Inc. (Massachusetts, USA), Flexcon Inc.(Massachusetts, USA), ETC Technologies Inc. (Massachusetts, USA), andMedical Adhesive Tape Technologies Inc. (New York, USA). Films availablefrom Dartex Coatings may include, but not limited to, DartexTC84. Filmsavailable from DermaMed Coatings Company may include, but not limitedto, DermaMed4 mil PU. Films available from Argotec may include, but notlimited to, Argotec2 mil PU. Films available from Flexcon may include,but not limited to, FlexconV400 and V600. Films available from ETCTechnologies may include, but not limited to, ETC 2 mil, 3 mil, 4 mil,and 6 mil. Films available from Medical Adhesive Tape Technologies mayinclude, but not limited to, M.A.T.T. 2.5GA PU, M.A.T.T. 3.0GA Vinyl,and M.A.T.T. 3.5GA vinyl. The film layer may be non-cytotoxic,hypoallergenic, resistant to bacterial growth, or a combination thereof.The film layer may have a dyne level of 36 dynes/cm or greater, 37dynes/cm or greater, 38 dynes/cm or greater, 39 dynes/cm or greater, 40dynes/cm or greater, for the side that will come into contact with theadhesive in the final construction.

Any suitable adhesive may be used herein. For example,pressure-sensitive adhesives (PSA), permanent adhesives, adhesives thatcure with time, light-activated adhesives that cure with electromagneticenergy such as UV or visible light, or heat-activated adhesives may beused. The adhesive may be non-cytotoxic, hypoallergenic, resistant tobacterial growth, or a combination thereof. The adhesive may be in theform of an adhesive layer.

A pressure-sensitive adhesive may comprise polyurethane, siliconepolymer, or other synthetic polymer based adhesive, and may or may notbe cross-linked. Adhesives are available commercially from, for example,Adchem Inc. (New York, USA), 3M Canada Inc. (Ontario, Canada). FlexconInc. (Massachusetts, USA), and Medical Adhesive Tape Technologies Inc.(New York, USA). Adhesives from Adchem may include, but not limited to,Adchem 7833, Adchem 653, Adchem 7603, Adchem 7854, Adchem 7333 andAdchem 730. Adhesives from 3M may include, but not limited to, 3M9465.Adhesives from Flexcon may include, but not limited to, Flexmark TT200.Adhesives from Medical Adhesive Tape Technologies may include, but notlimited to, COL-RZ002, COL-ACR003 and COL-ACR007.

In certain aspects, the present patches preferably are able to elongateat least 30%. For example, 31% or more, 32% or more, 33% or more, 34% ormore, 35% or more, 36% or more, 37% or more, 38% or more, 39% or more,40% or more. While not wishing to be bound by theory it is believed thatthe ability to elongation reduces the risk of peeling or separation fromthe surface of the medical device while in use. Peeling or separationcould reduce the efficacy of cleaning and/or disinfection proceduresthus creating a potential reservoir for pathogens. The average ofelongation may be measured by any suitable method such as, for example,ASTM D882.

In certain aspects, the present patches preferably have an average edgethickness of 10 mil or less, such as 9 mil or less, 8 mil of less, 7 milor less, 6 mil or less. While not wishing to be bound by theory it isbelieved that thicker patches can present a risk of peeling orseparation from the surface occurring. Peeling or separation couldreduce the efficacy of cleaning and/or disinfection procedures thuscreating a potential reservoir for pathogens. The edge thickness may bemeasured by any suitable method such as, for example, using thicknessgauges available from Mitutoyo or Mahr.

In certain aspects, the present patches preferably have an adhesionvalue of at least about 2.5 lbs/inch for at least 7 days afterapplication wherein the temperature is 16-21° C. and the relativehumidity is 15-50%. For example, the adhesion value may be 2.6 lbs/inch,2.7 lbs/inch, 2.8 lbs/inch, 2.9 lbs/inch, 3.0 lbs/inch. While notwishing to be bound by theory it is believed that patches with loweradhesion values can present a risk of peeling or separation from thesurface occurring. Peeling or separation could reduce the efficacy ofcleaning and/or disinfection procedures thus creating a potentialreservoir for pathogens. The adhesion value may be measured by anysuitable method such as, for example, ASTM D3330 or PSTC-101.

Health care devices may be subjected to cleaning and disinfection via anumber of methods. For example, mattresses on hospital beds may becleaned with compositions comprising hydrogen peroxide, sodiumhypochlorite, ammonium-based cleaning compositions, isopropanol, or thelike. In certain embodiments, the present patches are resistant to oneor more of such compositions. That is, the performance of the patches insitu is not significantly affected by transitory but repeated exposureto the cleaning solution.

The present patches may be provided in any suitable shape such as, forexample, square, rectangle, circle, oval, rhomboid, cross, or the like.The present patches may be provided in a roll or sheet form. In certainembodiments the patch may be trimmed to the desired size beforeapplication. The present patches may be provided in any suitable size.For example, the maximum diameter of the present patches may be 1 cm ormore, 2 cm or more, 3 cm or more, 4 cm or more, 5 cm or more, 6 cm ormore, 7 cm or more, 8 cm or more, 9 cm or more, 10 cm or more, 11 cm ormore, 12 cm or more, 13 cm or more, 14 cm or more, 15 cm or more. Themaximum diameter of the present patches may be 100 cm or less, 95 cm orless, 90 cm or less, 85 cm or less, 80 cm or less, 75 cm or less.

The present patches may comprise an anti-microbial agent. As usedherein, the term “anti-microbial” means the reduction or inhibition ofmicrobial bioburden, colonization, or attachment by microbial organisms.Antimicrobial agents include but not limited to, antibiotics,antiseptics, biocides, or other antimicrobial compounds, such as, forexample, silver, silver nanoparticles, ionic silver, combinations of oneor more one silver compounds, other metals such as zinc, copper, gold,platinum, and their salts or complexes, for example, zinc undecylenate,quaternary ammonium salts, isoniazid, ethambutol, pyrazinamide,streptomycin, clofazimine, rifabutin, fluoroquinolones, ofloxacin,sparfloxacin, rifampin, azithromycin, clarithromycin, dapsone,tetracycline, erythromycin, ciprofloxacin, doxycycline, ampicillin,amphotericin B, ketoconazole, fluconazole, pyrimethamine, sulfadiazine,clindamycin, lincomycin, pentamidine, atovaquone, paromomycin,diclazaril, acyclovir, trifluorouridine, foscarnet, penicillin,gentamicin, ganciclovir, iatroconazole, miconazole, Zn-pyrithione,chlorohexidine, polyhexamethylenebiguanides,polyhexamethylenebiguanides, triclosan, iodine,iodinepolyvinylpyrrolidone complex, urea-peroxide complex, benzalkoniumsalts, quaternary ammonium compounds based on saccharinate, algaecides,carbamates, cyanates, turmeric extract, other natural anti-infectivecompounds and combinations thereof. Anti-microbial agents may beeffective against one or more bacteria from the genus Bordetella,Borrelia, Brucella, Campylobacter, Chlamydia, Chlamydophilia,Clostridium, Corynebacterium, Enterococcus, Escherichia, Francisella,Haemophilus, Helicobacter, Legionella, Leptospira, Listeria,Mycobacterium, Mycoplasma, Neisseria, Pseudomonas, Rickettsia,Salmonella, Shigella, Staphylococcus, Streptococcus, Treponema, Vibrio,and/or Yersinia. For example, Bordetella pertussis, Borreliaburgdorferi, Brucella abortus, Brucella canis, Brucella melitensis,Brucella suis, Campylobacter jejuni, Chlamydia pneumoniae, Chlamydiatrachomatis, Chlamydophila psittaci, Clostridium botulinum, Clostridiumdifficile, Clostridium perfringens, Clostridium tetani, Corynebacteriumdiphtheriae, Enterococcus faecalis, Enterococcus faecium, Escherichiacoli, Francisella tularensis, Haemophilus influenzae, Helicobacterpylori, Legionella pneumophila, Leptospira interrogans, Listeriamonocytogenes, Mycobacterium leprae, Mycobacterium tuberculosis,Mycobacterium ulcerans, Mycoplasma pneumoniae, Pseudomonas aeruginosa,Rickettsia rickettsii, Salmonella typhi, Salmonella typhimurium,Shigella sonnei, Staphylococcus aureus, Staphylococcus epidermidis,Staphylococcus saprophyticus, Streptococcus agalactiae, Streptococcuspneumoniae, Streptococcus pyogenes, Treponema pallidum, Vibrio cholerae,Yersinia pestis, and the like. It is preferred that the presentanti-microbial agent be efficacious against Escherichia coli, Legionellapneumophila, Streptococcus pneumoniae, Streptococcus pyogenes, and thelike.

The present patches may contain an interlayer film to enhance therigidity and handling of the invention. This interlayer can be, but notlimited to, polyurethane, polyvinyl, polyester, kraft paper, or thelike. Such films are available commercially from Adhesive Films. Inc.(New Jersey, USA). Examples from Adhesive films may include, but notlimited to, UAF-472 1 mil, UAF-472 2 mil, and PAF-110 2 mil.

The present patches may comprise a release liner and/or a transfer lineron the film layer and/or adhesive layer to protect the patch before use.Such liners may also improve the ease of handling of the patch prior toapplication to device.

Referring to FIGS. 1A and 1B, an embodiment of a health care device 10is shown. The health care device 10 may be any device used in a healthcare environment, such as, for example, beds, tables, stools, wheelchairs, racks, trolleys, stretchers, mattresses, catheter-bags, andother furniture, equipment and articles used in a health careenvironment. The device 10 generally comprises a surface layer 12 and asupporting layer 14. The surface layer 12 defines at least a portion ofthe outer surface of the device 10 that may be subject to contact with aperson during the use of the device 10. The surface layer 12 may becomprised of any material suitable for a health care environment, suchas, for example, while not limited to, nylon, silicone, polyurethane,polyvinyl, polyethylene, polyamides and polyesters. The supporting layer14 supports the surface layer 12 and may be comprised of any materialsuitable to provide structural support to the surface layer 12, such as,for example, while not limited to, foam, wood, cotton, plastics, andmetals. In the alternative, the device 10 may not comprise a supportinglayer 14.

FIGS. 1A and 1B depict a damaged portion 20 of the surface layer 12. Thedamaged portion 20 may comprise one or more tears, punctures, rips,burns, wear, cracks, and other damage to the surface layer 12. Asdiscussed above, damaged portions 20 of surface layers 12 in health caredevices 10 are unattractive, unsanitary and present potential healthrisks by creating a host or reservoir for infectious agents.

Referring to FIGS. 2A and 2B, one embodiment of an adhesive patch 30 forrepairing damaged surfaces of a health care device 10 is shown. Thepatch 30 is applied to the surface layer 12 of the device 10 to coverthe damaged portion 20 and adhere to the surface layer 12. The patch 30is configured to be suitable for application in health careenvironments. In particular, amongst other suitable properties for ahealth care environment, the patch 30 may comprise one or more of thefollowing properties: physical properties, including, adhesion,anti-decubitus, heat-resistance, resistance to ultraviolet radiation,durability, flexibility, stretchable, breathability, cleanability,resistance to chemical cleaning products; anti-microbial properties,hypoallergenic and non-cytotoxic properties. The patch 30 comprises anadhesive layer 34 and a film layer 32.

Referring to FIGS. 3A and 3B, the patch 30 generally comprises a filmlayer 32, a peel-off layer 36, and an adhesive layer 34 disposed inbetween the film layer 32 and peel-off layer 36. Prior to application ofthe patch 30 to a health care device 10, the adhesive layer 34 functionsto adhere the film layer 32 and peel-off layer 36 into a unitary patch30. The film layer 32 and peel-off layer 36 protect the adhesive layer34 and prevent the adhesive layer 34 from adhering to other objects.During application of the patch 30 to the device 10, the peel-off layer36 is removed from the patch 30 and the adhesive layer 34 functions toadhere the film layer 32 to the surface layer 12 of the device 10. Theadhesive layer 34 may be comprised of any suitable adhesive suitable fora health care environment, such as, for example, acrylic, silicone. Inparticular, amongst other suitable properties for a health careenvironment, the adhesive layer 34 may comprise one or more of thefollowing properties: physical properties, including, adhesion to filmlayer and device surface, heat-resistance, pressure-resistance,resistance to ultraviolet radiation, durability, flexibility,cleanability, resistance to cleaning products, plasticizer resistant,anti-microbial properties, hypoallergenic and non-cytotoxic properties.

The film layer 32 comprises a top surface 42 and a bottom surface 44.The top surface 42 is an externally facing surface that may be subjectto contact with a person during use of the device 10; while the bottomsurface 44 is an interior surface that is adhered by the adhesive layer34, adhesive layer 34, adhesive layer 34 is also adhered to the toplayer 46 of the peel-off layer 36, which prior to application of thepatch 30 to the device 10 the peel-off-layer 36 is removed from theadhesive layer 34, and is adhered by the adhesive layer 34 to thesurface layer 12 of the device 10 during application of the patch 30 tothe device 10. The film layer 32 may be comprised of any materialsuitable for a health care environment, such as, for example, nylon,silicone, polyurethane, polyvinyl, polyethylene, polyamides andpolyesters. In particular, amongst other suitable properties for ahealth care environment, the film layer 32 may comprise one or more ofthe following properties: physical properties, including, adhesion orbonding to the adhesive, anti-decubitus, heat-resistance, resistance toultraviolet radiation, durability, flexibility, stretchable,breathability, cleanability, resistance to chemical cleaning products;anti-microbial properties, hypoallergenic and non-cytotoxic properties.

The peel-off layer 36 comprises a top surface 46 and a bottom surface48. The top surface 46 is an internal surface that is adhered by theadhesive layer 34 to the bottom surface 44 of the film layer 32, priorto application of the patch 30 to the device 10 and peel-off layer 36 isremoved from top surface 46 during application of the patch 30 to thedevice 10. The peel-off layer 36 may be comprised of any materialsuitable to be removably adhered to the film layer 32 by the adhesivelayer 34, such as, for example, kraft paper or polyester.

The present disclosure provides health care devices comprising a patchaccording to the present invention. The present disclosure provides amattress comprising a patch according to the present invention.

The present disclosure provides the use of a patch as described hereinfor repairing the surface of a health care device such as a mattress.Said use comprises applying the patch over the damaged portion of thesurface of the health care device.

The present disclosure provides a method of repairing the surface ofhealth care device by applying a patch according to the presentinvention over a damaged portion of the surface. The patch maycomprising a film layer and an adhesive layer. The patch may comprise ananti-microbial agent. The patch may comprise one or more of thefollowing properties: adhesion, heat-resistance, pressure-resistance,resistance to ultraviolet radiation, durability, flexibility,cleanability, resistance to cleaning products; anti-microbial, woundhealing, hypoallergenic and non-cytotoxic properties. The film layer maycomprise a polyvinyl, polyurethane, or the like. The adhesive layer maycomprise an acrylic, silicone, or the like. The patch may comprise apeel-off layer removably adhered to the film layer by the adhesivelayer.

It is contemplated that the different parts of the present descriptionmay be combined in any suitable manner. For instance, the presentexamples, methods, aspects, embodiments or the like may be suitablyimplemented or combined with any other embodiment, method, example oraspect of the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of ordinary skillin the art to which this invention belongs. Unless otherwise specified,all patents, applications, published applications and other publicationsreferred to herein are incorporated by reference in their entirety. If adefinition set forth in this section is contrary to or otherwiseinconsistent with a definition set forth in the patents, applications,published applications and other publications that are hereinincorporated by reference, the definition set forth in this sectionprevails over the definition that is incorporated herein by reference.Citation of references herein is not to be construed nor considered asan admission that such references are prior art to the presentinvention.

Use of examples in the specification, including examples of terms, isfor illustrative purposes only and is not intended to limit the scopeand meaning of the embodiments of the invention herein. Numeric rangesare inclusive of the numbers defining the range. In the specification,the word “comprising” is used as an open-ended term, substantiallyequivalent to the phrase “including, but not limited to,” and the word“comprises” has a corresponding meaning.

The invention includes all embodiments, modifications and variationssubstantially as hereinbefore described and with reference to theexamples and figures. It will be apparent to persons skilled in the artthat a number of variations and modifications can be made withoutdeparting from the scope of the invention as defined in the claims.Examples of such modifications include the substitution of knownequivalents for any aspect of the invention in order to achieve the sameresult in substantially the same way.

The present invention will be further illustrated in the followingexamples. However it is to be understood that these examples are forillustrative purposes only, and should not be used to limit the scope ofthe present invention in any manner.

EXAMPLES

28 different prototypes were developed based on a combination of 13commercially available film layers and 9 commercially availableadhesives layers. These prototypes were evaluated for their suitabilityin repairing damaged portions of the surfaces of health care devices.The film and adhesive layers were combined using standard manufacturingtechniques.

Patches were evaluated for their ability to withstand standard hospitalcleaning products.

Table 1 compares patch (Dartex+acrylic PSA, 3M and Adchem) relative toother tested compositions and that which is commercially available(Tear-Aid). Physical damages (cracking, shrinking, wrinkling) wasobserved for the material tested after 1 hour of immersion in the fourchemicals (5.5% Sodium Hypochlorite, 7% Hydrogen Peroxide, 70%Isopropanol, Ammonium Chloride)

TABLE 1 Adhesion Failure before 60 mins Sodium Hydrogen IsopropanolAmmonium Film Adhesive Surface Hypochlorite (5.5%) Peroxide (7%) (70%)Chloride Argotex PU 2 mil Flexmark TT200 Mattress Cover Yes n/a Yes n/aFlexcon V400 3M9465U Mattress Cover n/a n/a Yes n/a Flexon V400 FlexmarkTT200 Mattress Cover No Yes Yes n/a ETC 3mil PU Flexmark TT200 MattressCover Yes Yes Yes n/a Argotex PU 2 mil 3M 9465U Mattress Cover n/a n/aYes n/a ETC 3mil PU 3M 9465U Mattress Cover No No Yes No M.A.T.T.2.5 GAPU COL-RZO02 Mattress Cover n/a n/a Yes n/a M.A.T.T.3.0GA VinylCOL-ACR003 Mattress Cover n/a n/a Yes n/a M.A.T.T.5GA Vinyl COL-RZO02Mattress Cover n/a n/a Yes n/a ETC 3mil PU AdChem 730 Mattress Cover NoYes Yes No ETC 4mil PU AdChem 730 Mattress Cover No Yes Yes No DermaMed4mil 3M9465U Mattress Cover No No No No Dartex TC84 3M9465U MattressCover No No No No Dartex TC84 AdChem 7833 Mattress Cover No No No NoTear-Aid Mattress Cover No Yes Yes No Masta Plasta Mattress Cover YesYes Yes Yes Duct Tape Mattress Cover n/a n/a Yes n/aThe patch may comprise an antimicrobial additive. Table 2 summarizes thepresence or absence of an additive for a sample of patches.

TABLE 2 Composition Additive (film/adhesive) Dartex TC84/Adchem 7833Yes/Yes Dartex TC84/3M 9465U Yes/No  Tear-Aid No/No MastaPlasta No/NoDuct Tape No/NoThe patch may have a thickness of 10 mil or less after application tothe health care device. Table 3 summarizes the thickness of a sample ofpatches.

TABLE 3 Composition Thickness Dartex TC84/Adchem 7833 (5 mil) DartexTC84/3M 9465U (7 mil) Tear-Aid (12 mil)  MastaPlasta (>20 mil)  DuctTape (8 mil)The adhesive is preferably non-cytotoxic, hypoallergenic, and/orresistant to microbial growth. Table 4 summarizes these characteristicsfor certain adhesives.

TABLE 4 Composition Non-Cytotoxcitiy Adchem 7833 Yes 3M 9465U NoTear-Aid No MastaPlasta No Flexcon TT200 No Adchem 730 No ACR007 YesACR003 Yes RZ002 Yes Hypoallergenic Adchem 7833 Yes 3M 9465U No Tear-AidNo MastaPlasta No Flexcon TT200 No Adchem 730 No ACR007 Yes ACR003 YesRZ002 Yes Microbial Growth Sample S. aureus P. aeruginosa A.brasiliensis Control Heavy Growth Heavy Growth Heavy Growth 3M 9465U NoGrowth No Growth No Growth Tear-Aid Minimal Growth Minimal GrowthMinimal Growth AdhesiveThe film layer is preferably non-cytotoxic, hypoallergenic, and/orresistant to microbial growth. Table 5 summarizes these characteristicsfor certain films.

TABLE 5 Composition Non-Cytotoxic Dartex Yes Tear-Aid No MastaPlasta NoETC PU (3 mil, 4 mil, 6 mil) Yes 3M 7931 No DermaMed 4 mil Yes Argotex 2mil No Flexcon V400/V600 No Hypoallergenic Dartex Yes Tear-Aid NoMastaPlasta No ETC PU (3 mil, 4 mil, 6 mil) Yes 3M 7931 No DermaMed 4mil Yes Argotex 2 mil No Flexcon V400/V600 No Microbial Growth* Sample Saureus P aeruginosa A brasiliensis Control Heavy Growth Heavy GrowthHeavy Growth Dartext TC84 No Growth No Growth Minimal Growth Tear-Aid NoGrowth No Growth Minimal Growth *microbial growth rate of less than 10%based on test standard ASTM G21The adhesion value of the patch to the device is preferably 2.5 lbs/inchor greater 7 days after application at 16-21° C. and relative humidityof 15-50% relative humidity. Table 6 summarizes the performance ofcertain patches.

TABLE 6 180 degree Peel (lbs/in) Adchem Adeem Condition Test Surface 7307833 3M 465U Tear-Aid 1 day @ RT Stainless 5.9 3.9 3.3 5.2 Steel 1 day @RT Mattress 3.0 2.0 2.4 n/a Surface 7 day @ RT Stainless 9.1 4.9 4.4 n/aSteel 7 day @ RT Mattress 6.5 2.7 3.2 n/a Surface 7 day @ 150 Stainless9.1 6.9 7.7 n/a Steel 7 day @ 150 Mattress 3.6 3.8 4.6 n/a SurfaceIn summary, 2 samples made from the film Dartex TC84 and the adhesiveAdchem 7833 or 3M9465 were found to perform best against a variety ofcriteria required to be a function patch for the repair and regenerationof surface integrity on mattresses or other planar surfaces in a healthcare environment.

1. A repair patch for health care devices, said patch comprising a film layer and an adhesive wherein the patch has an average edge thickness of 10 mil or less.
 2. A repair patch for health care devices, said patch comprising a film layer and an adhesive wherein the patch has an average of elongation of 30% or greater.
 3. A repair patch for health care devices, said patch comprising a film layer and an adhesive wherein the patch has an adhesion value of at least about 2.5 lbs/inch.
 4. A patch according to any of claims 1 to 3, comprising an antimicrobial agent.
 5. A patch according to any of claims 1 to 4, wherein the film layer comprises polyethylene, polyurethane, polypropylene, nylon, silicone, polyamide, polyester, polyvinyl, or a combination thereof.
 6. A patch according to any of claims 1 to 5, wherein the film layer comprises polyvinyl, polyurethane, or a combination thereof.
 7. A patch according to any of claims 1 to 6, wherein the adhesive is a pressure-sensitive adhesive.
 8. A patch according to any of claims 1 to 7, wherein the adhesive is comprised within an adhesive layer.
 9. A patch according to any of claims 1 to 7, wherein the adhesive is comprised within an adhesive layer and the layer comprises acrylic.
 10. A patch according to any of claims 1 to 9, wherein the patch comprises a film layer and an adhesive layer, each layer having an average thickness of from 1 to 9 mils, wherein the average thickness of the two layers does not exceed 10 mils.
 11. A patch according to any of claims 1 to 10, wherein the health care device is a mattress.
 12. Use of a patch according to any of claims 1 to 11 for the repair of a health care device.
 13. A health care device comprising a patch according to any of claims 1-11.
 14. A method of repairing a health care device, said method comprising providing a patch according to any of claims 1 to 10 and adhering said patch to said health care device.
 15. The method of claim 14 wherein the health care device is a mattress. 